A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine

NCT06581575 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: JCXH-105-021
• Study Type: interventional
• Target: 467
• Locations: 1 country
• Sites: 8

Brief Summary

The goal of this clinical trial is to assess the safety and immunogenicity of an srRNA-based vaccine, JCXH-105, in the prevention of Herpes Zoster (Shingles). Subjects will be randomized to receive either JCXH-105 or Shingrix.

Conditions

Herpes Zoster (HZ); Infectious Diseases; Shingles

Keywords

srRNA; Herpes Zoster (HZ) vaccination; Healthy Subjects

Outcome Measures

Primary Outcomes (8)

• SAE Frequency

  Frequency of SAEs characterized by type, severity, duration, and relationship to the vaccine recorded from Day 1 post-vaccine administration through follow-up completion.

  Day 1 - Day 241 (Week 34)

• Solicited local reaction frequency

  Occurrence of solicited local injection site reactions characterize by frequency, severity, and duration within 7 days after each vaccine administration.

  Day 1 - Day 7 (After Dose 1), Day 1 - Day 7 (After Dose 2)

• Solicited systemic reaction frequency

  Occurrence of solicited systemic reactions characterize by frequency, severity, and duration within 7 days after each vaccine administration.

  Day 1 - Day 7 (After Dose 1), Day 1 - Day 7 (After Dose 2)

• AE Frequency

  Adverse events (AEs) including unsolicited AEs and any AEs leading to discontinuation of study vaccine or withdrawal from the study, characterized by frequency, severity, duration, and relationship to the vaccine from Day 1 post-vaccine administration through follow-up completion.

  Day 1 - Day 241 (Week 34)

• AESIs Frequency

  AESIs characterized by frequency, severity, duration, and relationship to the vaccine from Day 1 post-vaccine administration through follow-up completion.

  Day 1 - Day 241 (Week 34)

• Medically Attended AE Frequency

  Medically attended AEs (MAAEs) characterized by frequency, severity, duration, and relationship to the vaccine from Day 1 post-vaccine administration through follow-up completion.

  Day 1 - Day 241 (Week 34)

• Immune-Mediated Adverse Events of Special Interest Frequency

  Immune-mediated adverse events of special interest (imAESIs) characterized by frequency, severity, duration, and relationship to the vaccine (JCXH-105 or Shingrix) recorded from Day 1 post-vaccine administration through follow-up completion.

  Day 1 - Day 241 (Week 34)

• gE-Specific CD4+ T cell Response Rate

  Response Rate is defined at the percentage of subjects with ≥ 2 folds increase of gE-specific CD4+ T cells expressing 2 or more markers of activation (IFN-γ, IL-2, TNFα, and CD40L) in PBMCs analyzed with flow cytometry with ICS on Day 89 as compared to baseline (Day 1 pre-dose).

  Day 1 - Day 89 (Week 13)

Secondary Outcomes (1)

• Cellular immunogenicity of JCXH-105

  Day 1 - Day 241 (Week 34)

Other Outcomes (2)

• Cellular Immunogenicity of JCXH-105

  Day 1 - Day 241 (Week 34)

• Humoral immunogenicity of JCXH-105

  Day 1 - Day 241 (Week 34)

Study Arms (2)

Investigational Product

EXPERIMENTAL

Participants randomized to this arm will be given the investigational product (JCXH-105).

Biological: JCXH-105

Active Control

ACTIVE COMPARATOR

Participants randomized to this arm will be given the FDA approved Shingrix.

Biological: Shingrix

Interventions

JCXH-105 BIOLOGICAL

IM injection

Investigational Product

Shingrix BIOLOGICAL

IM injection

Active Control

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sex: Male or female; female subjects may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
• Age: ≥ 50 years of age at screening.
• Status: Healthy subjects.
• Subjects must agree to not be vaccinated with any HZ vaccine while participating in this study.
• Subjects must agree to not be vaccinated with any RNA-based vaccines (e.g., Spikevax, Comirnaty, etc.) 30 days before Dose 1 through 30 days after Dose 2 (a 4-month period).

You may not qualify if:

• Subjects with a history of HZ within the past 10 years or current diagnosis of HZ.
• Previous vaccination against HZ.
• Subjects with any respiratory illness deemed clinically relevant by the Investigator within the past month OR hospitalization \>24 hours for any reason within the past month prior to the first vaccine administration (JCXH-105 or Shingrix).
• Subjects who are acutely ill or febrile with body temperature ≥ 38.0º Celsius/100.4º Fahrenheit 72 hours prior to or at the Screening visit or on Day 1 pre-dose. Subjects meeting this criterion may be rescheduled within an allowable window with approval from the Sponsor.
• Subjects with history or current diagnosis of congenital or acquired immunodeficiency/immunocompromising/immunosuppressive conditions, asplenia, or recurrent severe infections. Certain immune-mediated conditions (e.g., Hashimoto thyroiditis) that are well controlled and stable are allowed.
• Subjects with history of myocarditis or pericarditis, or with AEs (including anaphylaxis and severe hypersensitivity) after mRNA vaccination that are in nature and severity beyond the common expected AEs and necessitating medical intervention.
• Subjects who received any non-live vaccine within 14 days prior to Day 1 (first dose of JCXH-105 or Shingrix).
• Subjects who received within 28 days prior to Day 1 (first dose of JCXH-105 or Shingrix): (1) Any live vaccine, (2) Immunomodulators or immune-suppressive medication, (3) Granulocyte or granulocyte-macrophage colony-stimulating factor, (4) Three or more consecutive days of systemic corticosteroids. Note: subjects on stable-dose steroid replacement (for chronic disease such as iatrogenic deficiency) of prednisone ≤10 mg/day or equivalent are allowed and (5) Other investigational agents or devices.
• Subjects receiving systemic antiviral therapy.
• Subjects with a positive screening test for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, anti-human HIV-1 and 2 antibodies, or syphilis.
• Subjects with a positive screening test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Sponsors & Collaborators

• Immorna Biotherapeutics, Inc.: lead
• Tigermed Consulting Co., Ltd: collaborator

Study Sites (8)

Noble Clinical Research

Tucson, Arizona, 85704, United States

Location

Long Beach Research Institute

Long Beach, California, 90805, United States

Location

DM Clinical Research - Chicago

Chicago, Illinois, 60652, United States

Location

Quality Clinical Research

Omaha, Nebraska, 68114, United States

Location

DM Clinical Research - New Jersey

Jersey City, New Jersey, 07306, United States

Location

Delricht Research

Charleston, South Carolina, 29407, United States

Location

Delricht Research

Prosper, Texas, 75078, United States

Location

DM Clinical Research - Sugarland

Sugar Land, Texas, 77478, United States

Location

MeSH Terms

Conditions

Herpes Zoster; Communicable Diseases

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple-blinded study
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 3, 2024
• Study Start: October 16, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (8)